PolyVascular · 12 hours ago
Product Development Engineer
Houston, TX
Full-time
Onsite
Mid, Senior LevelPolyVascular is transforming care of children with congenital heart disease by developing an entirely new generation of valves made of medical grade polymer. The Product Development Engineer will support the development of a novel heart valve for children, managing product builds, executing design verification studies, and preparing regulatory documentation.
BiotechnologyHealth CareManufacturingMedical DeviceService Industry
Hiring Manager
Stephen Dria
Responsibilities
Rapid Onboarding: Quickly learn the product and processes to accelerate development
Product Manufacturing: Ensure readiness for and manage product builds
Design Verification & Validation: Execute benchtop studies to confirm product performance and compliance to mechanical, durability, and ISO requirements
Biocompatibility & Preclinical Testing: Coordinate and interpret results from biocompatibility and animal studies
Early Feasibility Study: Assist in planning and preparation for First-in-Human study
Regulatory Support: Prepare documentation and assist with FDA interactions to enable first-in-human trials
Cross-functional Collaboration: Work closely with leadership and external partners
Qualification
Required
Masters or PhD in engineering (biomedical, mechanical, materials, tissue)
Medical device development experience under a Quality Management System
Familiarity with cardiovascular medicine and/or cardiovascular devices
CAD, computational modeling, and/or simulation skills
Creative problem solver and/or builder
Excellent technical writing skills
Excellent communicator comfortable presenting scientific data in a clear, concise manner to supervisors and team
Self-motivated, organized, and thorough
Desire to gain entrepreneurial / industry experience
Candidates must be legally authorized to work in the US (including OPT)
Occasional travel is required
Benefits
Health benefits
Company
PolyVascular
PolyVascular provides medical equipment manufacturing service.
Founded in 2014
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$2.83M2023-07-17Series Unknown· $0.8M
2023-07-12Grant· $2M
2020-05-16Grant· $0.03M
Leadership Team
Kwonsoo Chun
Co-Founder
William Clifton MD
Chief Operating Officer
Company data provided by crunchbase